Drug product
Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 678112000708; NDC 67172-504-01.
D-0469-2023
Product summary
- Event
- Event 91757
- Status
- Terminated
- Classification
- Class II
- Quantity
- 715,632 bottles
- Official record key
drug-enforcement:D-0469-2023
Official wording
Reason: Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Code information: Lot #114349, Exp. 05/2023; 117396, Exp. 09/2023; 120128, Exp. 11/2023; 114371, Exp. 06/2023; 123781, Exp. 02/2024.
Distribution pattern: Nationwide in the U.S.A.
Derived failure modes
-
Potency or specification failure
Out-of-specification